Pregnant women at higher risk for preeclampsia (PE) are currently recommended to take low-dose aspirin (acetylsalicylic acid, ASA) daily from the first trimester until 36 weeks of gestation. High-risk women are identified through a multiparametric first-trimester screening that combines maternal history, blood pressure, uterine artery blood flow, and placental growth factor (PlGF). Although this screening effectively identifies women at risk, the majority of those classified as high risk will not develop PE. As a result, a large proportion of pregnant women receive prolonged aspirin treatment without benefit, while remaining exposed to its potential side effects, including increased bleeding risk.
Aspirin prevents PE primarily by improving placental development during the first half of pregnancy. Whether continuing ASA beyond 24-28 weeks provides additional protection remains unclear. A previous randomized trial demonstrated that stopping ASA at 24-28 weeks was non-inferior to continuing until 36 weeks in a predominantly European population. However, whether this finding applies to more diverse populations, including women of African origin who carry a substantially higher baseline risk of PE, has not been established.
This is a multicenter, randomized, open-label, parallel-group, phase III non-inferiority trial conducted across sites in Europe and Africa. A total of 15,160 pregnant women at high risk for PE from first-trimester screening, currently under ASA treatment, will be randomized in a 1:1 ratio before 28 weeks of gestation to either discontinue ASA at 24-28 weeks or continue ASA until 36 weeks of gestation.
Age 18 years or older at time of enrollment.
Singleton pregnancy.
Ability to read and understand the informed consent form.
Having undergone first-trimester preeclampsia screening between 11+0 and 13+6 weeks of gestation using a validated multiparametric algorithm (FMF algorithm at a risk cutoff of 1:100, or Gaussian algorithm at a cutoff of 1:170) and being classified as high risk for preterm preeclampsia.
Early pregnancy loss, intrauterine fetal death, or fetus with major structural malformations diagnosed at the time of enrollment.
Fetus affected by a known genetic or chromosomal disease.
Contraindication, allergy, or intolerance to aspirin (acetylsalicylic acid).
Any medical condition that makes aspirin discontinuation unsafe or impossible (e.g., antiphospholipid syndrome, mechanical heart valve, or other conditions requiring indefinite antiplatelet or anticoagulant therapy).
Parallel
Discontinuation of Acetylsalicilic acid 150 mg/day at 24-28 weeks of gestation
DrugIntervention group will discontinuate of Acetyl Salicylic acid at 24-28 weeks of gestation while Control Group will continue Acetyl Salicylic acid 150 mg/day until 36 weeks of gestation.
Rate of preterm preeclampsia in both arms of the study (ASA vs no ASA).
Rate of pre-eclampsia \<37 weeks in pregnant women at high-risk for early-onset PE from the first-trimester screening in both arms of the study (ASA vs no ASA).
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Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
Fetal Medicine Foundation
Collaborator
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